Hi John I think we are enjoying a small climax rally in here... looks a little lame.. I wonder if the news about IVAX is raining on our parade??
FDA Responds to IVAX's Paxene(R) Application
MIAMI, Dec. 26 /PRNewswire/ -- IVAX Corporation (Amex: IVX - news) announced today that its subsidiary, Baker Norton Pharmaceuticals, Inc., received a tentative approval from the United States Food and Drug Administration of its New Drug Application for Paxene(R) to treat Kaposi's sarcoma after failure of first line or subsequent systemic chemotherapy. In granting the tentative approval, the FDA concluded that Paxene(R) is safe and effective for this indication. Paxene(R) is
Baker Norton's registered trademark for the compound paclitaxel (referred to in some scientific and medical literature as taxol*). Earlier this year, Bristol-Myers Squibb Company (NYSE: BMY -
news) received approval to market its version of paclitaxel, called Taxol(R), for a related indication for which Taxol(R) received seven years of market exclusivity under the provisions of the Orphan
Drug Act. That act provides for market exclusivity for drug products approved to treat diseases or conditions affecting fewer than 200,000 persons in the United States. The FDA has indicated that, in
view of Taxol(R)'s orphan drug exclusivity for a related indication, the application by Baker Norton may not be finally approved until August 4, 2004. Baker Norton anticipated that obtaining marketing
approval of Paxene(R) for this indication would be a difficult challenge and is exploring alternative strategies to market Paxene(R) for Kaposi's sarcoma in advance of the expiration of Taxol(R)'s
orphan drug exclusivity.
Baker Norton noted that Taxol(R)'s market exclusivity does not apply to the use of paclitaxel to treat other indications or to Abbreviated New Drug Applications. Baker Norton has conducted clinical studies of Paxene(R) for other indications, and intends to file an application for the use of Paxene(R) to treat one or more of such other indications.
what are YOUR Thoughts John???
luis |
